Covid-19 Living Data

Trial NCT04647695
Publication Tam A, Clin Infect Di (2022) (published paper)
Dates: 2020-11-01 to 2021-02-28
Funding: Public/non profit (This study was partly supported by the Health and Medical Research Fund (Project no.: COVID190125), Hong Kong Special Administrative Region, China; Health@InnoHK, Innovation and Technology Commission, the Government of the Hong Kong Special Administrative Region; and the Consultancy Service for Enhancing Laboratory Surveillance of Emerging Infectious Diseases and Research Capability on Antimicrobial Resistance for Department of Health of the Hong Kong Special Administrative Region Government; and donations from Richard Yu and Carol Yu, May Tam Mak Mei Yin, the Shaw Foundation of Hong Kong, Michael Seak-Kan Tong, Lee Wan Keung Charity Foundation Limited, the Providence Foundation Limited (in memory of the late Dr Lui Hac Minh), Hong Kong Sanatorium and Hospital, Hui Ming, Hui Hoy and Chow Sin Lan Charity Fund Limited, Chan Yin Chuen Memorial Charitable Foundation, Marina Man-Wai Lee, the Hong Kong Hainan Commercial Association South China Microbiology Research Fund, the Jessie & George Ho Charitable Foundation, Perfect Shape Medical Limited, Kai Chong Tong, Tse Kam Ming Laurence, Foo Oi Foundation Limited, Betty Hing-Chu Lee, and Ping Cham So. )
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / China (Hong Kong SAR) Follow-up duration (days): 30
Inclusion criteria	Adult patients ≥18 years hospitalized for virologic confirmed SARS-CoV-2 infection Fulfilling one of the following criteria associated with high risk of clinical deterioration: age 65 years or above, radiological evidence of pneumonia, oxygen desaturation <94% on room air, comorbidity including hypertension, diabetes, cardiovascular diseases, chronic obstructive lung disease, chronic liver diseases, chronic kidney diseases, malignancy, haematological diseases, rheumatological diseases, immunocompromised hosts and obesity (BMI > 30) written informed consent. For patients who are critically ill, requiring ICU, ventilation or confused, informed consent will be obtained from spouse, next-of-kin or legal guardians available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion criteria	Inability to comprehend and to follow all required study procedures Allergy or severe reactions to the study drugs taking medication that will potentially interact with l interferon beta-1b and remdesivir known history of severe depression Estimated glomerular filtration rate <30 mL/min Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study To participate in an unrelated trial during the current clinical trial. Nevertheless, the patients have the right to withdraw from the current clinical trial to join another clinical trial history of alcohol or drug abuse in the last 5 years any condition that the investigator believes may interfere with successful completion of the study.
Interventions
	Treatment INF BETA-1b+RDV INF BETA-1b: 16 million units (2 ml) subcutaneously daily for 5 days + RDV: Initial dose: 200 mg IV infusion on day 1 -Maintenance dose: 100 mg IV infusion daily on days 2 to 5.
	Control Remdesivir 200 mg intravenously once on day 1 followed by 100 mg intravenously once a day on days 2-5
Participants
	Randomized participants : Remdesivir=104 INF BETA-1b+RDV=108
	Characteristics of participants N= 212 Mean age : NR 112 males Severity : Mild: n= 163/ Asymptomatic: n=28 Number of vaccinated participants: NR
Primary outcome
	In the register Clinical improvement [ Time Frame: 30 days ] Time to complete alleviation of symptoms as defined by NEWS of 0 maintained for 24 hours.
	In the report Time to complete alleviation of symptoms as defined by the National Early Warning Score 2 (NEWS2) = 0 maintained for 24 hours
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the retrospective trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 212) achieved its target sample size (n = 180).